NCT07732647

Brief Summary

This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Gum Disease

Outcome Measures

Primary Outcomes (2)

  • Linear changes of gum tissue architecture

    Digitally measured soft tissue changes in mm\^2 using intraoral and CBCT scans

    1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery

  • Volumetric changes of gum tissue architecture

    Digitally measured soft tissue changes in mm\^3 using intraoral and CBCT scans

    1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery

Secondary Outcomes (3)

  • Changes in marginal bone

    5 months after baseline surgery, 6 months and 12 months after crown delivery

  • Patient-reported satisfaction

    14 days after baseline surgery

  • Microbial profile

    Baseline, 4 months after baseline surgery, 6 months and 12 months after crown delivery

Study Arms (2)

Provisional crown

ACTIVE COMPARATOR

A provisional (temporary) crown will be placed on the dental implant after it is placed.

Device: Dental implant placement

Healing cap

ACTIVE COMPARATOR

A healing cap will be placed on the dental implant after it is placed.

Device: Dental implant placement

Interventions

Dental implant placementDEVICE

A dental implant will be placed after tooth extraction.

Healing capProvisional crown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
  • Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).
  • Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)
  • More than 20 occluding teeth with stable occlusion.
  • Nonsmokers or smokers \< 10 cig/day (self-reported).

You may not qualify if:

  • Presence of uncontrolled or untreated periodontal disease.
  • Presence of active periapical infection.
  • Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c \> 8)).
  • Pregnant subjects or individuals attempting to get pregnant (self-reported)
  • Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
  • Subjects unable to maintain adequate oral hygiene
  • Insufficient restorative space or bite collapse.
  • Lack of primary implant stability assessed intrasurgically.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Hom-Lay Wang, DDS MSD PhD

    Department of Periodontics and Oral Medicine, University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)